NDT Effectiveness Study

Sponsor

MultiCare Health System Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05070910

Collaborator

(none)

Enrollment

Location

Arm

11.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether there is a functional change in children with Cerebral Palsy (CP) and other neuromuscular disorders participating in Neurodevelopmental Treatment (NDT) intervention using the contemporary practice model (CPM).

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Neuromuscular Diseases Neurodevelopment Treatment	Behavioral: Therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Determining the Efficacy of the Neurodevelopmental Treatment Contemporary Practice Model for the Treatment of Children With Cerebral Palsy or Other Neuromuscular Conditions to Improve Functional Outcomes.

Actual Study Start Date :

Oct 25, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NDT Therapy will be provided 2 days to 4 days per week for one-hour sessions	Behavioral: Therapy The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs

Arm

Intervention/Treatment

Experimental: NDT

Therapy will be provided 2 days to 4 days per week for one-hour sessions

Behavioral: Therapy

The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs

Outcome Measures

Primary Outcome Measures

Significant increase in functional outcomes in COPM scores [Significant change after an 8 week NDT-CPM treatment occurring from November 2, 2021 to completion on March 12, 2022]
Change functional outcomes in COPM scores after NDT-CPM treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The children will be aged 2 to 15 years with a diagnosis of CP, hypotonia, global developmental delay and/ or neuromuscular disorders not otherwise specified.
Children must also be willing to receive physical guidance for movement and clearly attempt to respond to simple instructions on request.
Children and their families are available and willing to attend the practicum portion of the course for both blocks.

Exclusion Criteria:

Parent/Guardian unable to complete the 4 required interview sessions.
Unable to commit to attending 75% of practicum sessions.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Good Samaritan Hospital	Puyallup	Washington	United States	98372

Sponsors and Collaborators

MultiCare Health System Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

MultiCare Health System Research Institute

ClinicalTrials.gov Identifier:

NCT05070910

Other Study ID Numbers:

2021/04/10

First Posted:

Oct 7, 2021

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebral Palsy

Neuromuscular Diseases

Study Results

No Results Posted as of Aug 8, 2022